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The Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or older and by prescription only.

The device is contraindicated for use on critical care patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD), and left ventricular assist devices (LVAD); for use in magnetic resonance (MR) environments; for use during surgical procedures when electro-surgical equipment is optional. The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions.

The Life Sensor Cardiac Monitor (CM) Platform is a wireless data collection system that monitors physiological data (electrocardiograph and heart rate) and consists of the following sub-systems:

Life Sensor Electrode (includes Life Sensor Patch and Life Sensor Module)
Life Sensor Firmware
Life Sensor Application

Life Sensor Electrode

• Life Sensor Patch: The Life Sensor Patch is the single-use, self-adhesive interface to a patient that is attached to the patient's upper torso region just above the heart.
• . Life Sensor Module: The Life Sensor Module attached to the Life Sensor Patch, contains the battery powered electronics and sensing apparatus necessary to operate the system. The Life Sensor Module automatically performs all the processing functions related to capturing the required physiological data from the body and performs encrypted, bi-directional communication to the Life Sensor Application, using Bluetooth Low Energy (BLE), when in range of the Life Sensor Application installed on a paired iOS device.
• Life Sensor Firmware:

The Life Sensor Firmware is the software installed on the Life Sensor Module. The Life Sensor Firmware manages bi-directional communication between the Life Sensor Module and the Life Sensor Application. Encrypted data is transmitted to and from the Life Sensor Module and the Life Sensor Application.

• . Life Sensor Application: The Life Sensor Application, installed on a paired iOS device, interacts with the Life Sensor Firmware and manages the upload, processing, and display of the physiological data transmitted by the Life Sensor Module.
  When installed on a compatible hardware, the Life Sensor Application establishes connection to any of the Life Sensor Electrode through pairing process.

Life Sensor Application has visual alarms to alert clinical personnel when heart rate of the person being monitored is outside the set limits, lead off, asystole, tachycardia and bradycardia, when the battery is low, or when there is loss of communication between the Life Sensor Application and the Life Sensor Electrode.

The provided text describes the Life Sensor Cardiac Monitor (CM) Platform and its 510(k) summary, comparing it to a predicate device, the LifeSignals WiPatch & WiApp System (K172011).

However, the document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with specific statistical results to "prove" the device meets acceptance criteria in the way a clinical trial or algorithm performance study might. The information provided is primarily related to non-clinical testing for safety and basic performance.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the form of specific quantitative thresholds in a table for most performance aspects. Instead, it states technical specifications and implies compliance with standards.

Missing Information/Detail:

• Specific numerical acceptance criteria for biocompatibility, electrical safety, software V&V, and usability are not detailed, only that the device "complies" with the relevant standards.
• The exact results of the shelf life, packaging integrity, and operation/storage conditions bench testing are not provided.
• The document does not include any clinical performance data or studies comparing the device's accuracy in detecting medical conditions (as it states it "does not detect or diagnose medical conditions"). The focus is on accurate physiological data monitoring.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" or "training set" in the context of an algorithm's performance on patient data. The non-clinical testing mentioned (biocompatibility, electrical safety, software V&V, usability, bench testing) would have their own sample sizes (e.g., number of units tested for electrical safety, number of participants for usability) but these are not provided in the summary.

Data provenance: Not applicable in the context of algorithm performance on patient data, as no such study is described. The non-clinical tests would have been performed in a laboratory or controlled environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable, as no algorithm performance or diagnostic study on a test set (with human-established ground truth) is described.

4. Adjudication Method for the Test Set

Not applicable, as no algorithm performance or diagnostic study on a test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or described in this document. The device is a "monitor" and does not perform diagnostic interpretations that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study is not mentioned or described. The device's primary function is to monitor and transmit physiological data (ECG and heart rate) for review by healthcare professionals on an iOS application. It explicitly states, "The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions."

7. The Type of Ground Truth Used

For the basic physiological measurements (heart rate, ECG display), the "ground truth" would implicitly be derived from highly accurate, calibrated reference measurement devices used during "bench testing" or controlled physiological simulations, rather than pathology, expert consensus, or outcomes data, as the device is not for diagnosis. However, the details of how accuracy was measured against a reference are not provided, only the specified accuracy range.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm requiring a "training set" for diagnostic or predictive purposes is described.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no machine learning algorithm requiring a "training set" is described.

Summary of Device Purpose:
The Life Sensor Cardiac Monitor is presented as a wireless monitoring system for healthcare professionals to monitor physiological data (heart rate and ECG) in healthcare settings. It transmits data to an iOS application for review. The focus of the 510(k) submission is to demonstrate substantial equivalence to an existing predicate device (LifeSignals WiPatch & WiApp System) through non-clinical testing for safety and basic performance (biocompatibility, electrical safety, software V&V, usability, bench testing), rather than through clinical trials or algorithm performance studies that would involve large patient datasets and established ground truths for diagnostic accuracy. The device monitors, but does not detect or diagnose medical conditions.

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